Staged-deployment stent graft assembly having a sacrifical port

ABSTRACT

A staged-deployment stent graft assembly. A main stent graft has a sacrificial port extending therefrom. The stent graft has a compressed state and an expanded state. The staged-deployment stent graft assembly also includes an internal stent cuff located within the stent graft. The internal stent cuff has a constricted state and a non-constricted state. The internal stent cuff may be biased to expand from the constricted state to the non-constricted state to close the sacrificial port when the main stent graft is in the expanded state. The assembly also includes a filament structure maintaining the internal stent cuff in the constricted state. The assembly further includes a release configured to manipulate the filament structure to transition the internal stent cuff from the constricted state to the non-constricted state to close the sacrificial port when the main stent graft is in the expanded state.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.16/930,980 filed Jul. 16, 2020, the disclosure of which is herebyincorporated in its entirety by reference herein.

TECHNICAL FIELD

The present disclosure relates generally to a stage-deployment stentgraft assembly having a sacrificial port.

BACKGROUND

Prostheses are implanted in blood vessels and other organs of livingbodies. For example, prosthetic endovascular grafts constructed ofbiocompatible materials have been employed to replace or bypass damagedor occluded natural blood vessels. In general, endovascular graftsinclude a graft anchoring component that operates to hold a tubulargraft component of a suitable graft material in its intended positionwithin the blood vessel. The graft anchoring component typicallyincludes one or more radially-compressible stents that are radiallyexpanded in situ to anchor the tubular graft component to the wall of ablood vessel or anatomical conduit.

Rather than performing a traumatic and invasive open surgical procedureto implant a graft, endovascular grafts (e.g., stent grafts) may bedeployed through a less invasive intraluminal delivery procedure. Alumen or vasculature may be accessed at a convenient and less traumaticentry point of the patient's body, and the stent graft may be routedthrough the vasculature to the site where the prosthesis is to bedeployed. Intraluminal deployment typically uses a delivery catheterwith tubes or shafts arranged for relative axial movement. For example,an expandable stent graft may be compressed and disposed within a distalend of an outer shaft of the delivery catheter fixed to an inner shaft.The delivery catheter may then be maneuvered, typically tracked througha body lumen until a distal end of the delivery catheter and the stentgraft are positioned at the intended treatment site. The stent graft canthen be deployed and radially expanded within the blood vessel.

SUMMARY

According to an embodiment, a staged-deployment stent graft assembly isdisclosed. The assembly includes a main stent graft has a sacrificialport extending therefrom. The stent graft has a compressed state and anexpanded state. The staged-deployment stent graft assembly also includesan internal stent cuff located within the stent graft. The internalstent cuff has a constricted state and a non-constricted state. Theinternal stent cuff may be biased to expand from the constricted stateto the non-constricted state to close the sacrificial port when the mainstent graft is in the expanded state. The assembly also includes afilament structure maintaining the internal stent cuff in theconstricted state. The assembly further includes a release configured tomanipulate the filament structure to transition the internal stent cufffrom the constricted state to the non-constricted state to close thesacrificial port when the main stent graft is in the expanded state.

According to another embodiment, a staged-deployment stent graftassembly is disclosed. The assembly includes a main stent graft has asacrificial port extending therefrom. The stent graft has a compressedstate and an expanded state. The staged-deployment stent graft assemblyalso includes an internal stent cuff located within the stent graft. Theinternal stent cuff has a constricted state and a non-constricted state.The assembly includes filament loops maintaining the internal stent cuffin the constricted state. The assembly further includes a releaseconfigured to manipulate the filament loops to transition the internalstent cuff from the constricted state to the non-constricted state toclose the sacrificial port when the main stent graft is in the expandedstate.

According to yet another embodiment, a staged-deployment stent graftassembly is disclosed. The assembly includes a main stent graft has asacrificial port extending therefrom. The stent graft has a compressedstate and an expanded state. The staged-deployment stent graft assemblyalso includes an internal stent cuff located within the stent graft. Theassembly further includes a sheath maintaining the internal stent cuffin the constricted state and having first and second ends. The assemblyalso includes a removable tie configured to tie the first and secondends of the sheath. When the removable tie is removed, the internalstent cuff transitions from the constricted state to the non-constrictedstate to close the sacrificial port when the main stent graft is in theexpanded state.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a stent graft installed into a blood vessel,for example an aorta, according to an embodiment.

FIG. 2 is a schematic illustration of a stent graft delivery system,according to one embodiment.

FIG. 3 is a side view of a stent graft assembly installed into abranched artery, in which the stent graft assembly includes two stentgrafts each having a sacrificial port, according to one embodiment.

FIG. 4A is a side view of the stent graft assembly of FIG. 3 with aguidewire passing from one sacrificial port of one stent graft toanother sacrificial port of another stent graft, according to oneembodiment; FIG. 4B is an enlarged view of a region of FIG. 4A, with theguidewire removed and the sacrificial ports subsequently closed,according to one embodiment; FIGS. 4C-4K illustrate various embodimentsof methods of closing the sacrificial ports, with each embodiment shownin both an open configuration and a closed configuration.

FIG. 5A is a side view of a stent graft assembly installed into abranched artery, according to another embodiment in which a guidewireand delivery system is fed into a sacrificial port of one stent graft,and out through a leg of that stent graft, with an internal cuff in aconstricted configuration; FIG. 5B is a view similar to FIG. 5A, withthe guidewire and delivery system removed, and the internal cuff in anexpanded configuration.

FIGS. 6A and 6B illustrate a staged-deployment system for closing asacrificial port of a stent graft, according to one embodiment.

FIGS. 7A and 7B illustrate a staged-deployment system 00 for closing asacrificial port of a stent graft, according to another embodiment.

DETAILED DESCRIPTION

Embodiments of the present disclosure are described herein. It is to beunderstood, however, that the disclosed embodiments are merely examplesand other embodiments can take various and alternative forms. Thefigures are not necessarily to scale; some features could be exaggeratedor minimized to show details of particular components. Therefore,specific structural and functional details disclosed herein are not tobe interpreted as limiting, but merely as a representative basis forteaching one skilled in the art to variously employ the embodiments. Asthose of ordinary skill in the art will understand, various featuresillustrated and described with reference to any one of the figures canbe combined with features illustrated in one or more other figures toproduce embodiments that are not explicitly illustrated or described.The combinations of features illustrated provide representativeembodiments for typical applications. Various combinations andmodifications of the features consistent with the teachings of thisdisclosure, however, could be desired for particular applications orimplementations.

Directional terms used herein are made with reference to the views andorientations shown in the exemplary figures. A central axis is shown inthe figures and described below. Terms such as “outer” and “inner” arerelative to the central axis. For example, an “outer” surface means thatthe surfaces faces away from the central axis, or is outboard of another“inner” surface. Terms such as “radial,” “diameter,” “circumference,”etc. also are relative to the central axis. The terms “front,” “rear,”“upper” and “lower” designate directions in the drawings to whichreference is made.

Unless otherwise indicated, for the delivery system the terms “distal”and “proximal” are used in the following description with respect to aposition or direction relative to a treating clinician. “Distal” and“distally” are positions distant from or in a direction away from theclinician, and “proximal” and “proximally” are positions near or in adirection toward the clinician. For the stent-graft prosthesis,“proximal” is the portion nearer the heart by way of blood flow pathwhile “distal” is the portion of the stent-graft further from the heartby way of blood flow path.

The following detailed description is merely exemplary in nature and isnot intended to limit the invention or the application and uses of theinvention. Although the description is in the context of treatment ofblood vessels such as the aorta, coronary, carotid and renal arteries,the invention may also be used in any other body passageways where it isdeemed useful

Endovascular stent grafting, or endovascular aneurysm repair (EVAR), isa form of treatment for abdominal or thoracic aortic aneurysm that isless invasive than open surgery. Endovascular stent grafting uses anendovascular stent graft to reinforce the wall of the aorta and to helpkeep the damaged area from rupturing by excluding the aneurysm fromblood flow. Stent grafts are generally tubular open-ended structuresproviding support for damaged, collapsing, or occluded blood vessels,such as the aorta. Stent grafts are flexible, which allows them to beinserted through, and conform to, tortuous pathways in the bloodvessels. For example, stent grafts may be radially expandable from aradially-compressed (or radially-constricted) configuration for deliveryto the affected vessel site to a radially-expanded configuration whendeployed at the affected vessel treatment site, with theradially-expanded configuration having a larger diameter than theradially-compressed configuration. Stent grafts may be inserted in theradially compressed configuration and expanded to the radially-expandedconfiguration either through a self-expanding mechanism, or through theuse of a balloon catheter, for example.

In one example, an EVAR procedure may include inserting a guide wireinto a portion of the patient's body, such as the femoral artery. Oncethe guidewire is inserted into the artery, it may be gently pushedtoward the site of the aneurism. A stent graft delivery system, whichmay include a catheter and stent graft, may be placed over the guidewireand inserted along the guidewire into the site of the aneurism. Thestent graft may be guided within the catheter in its radially-compressedconfiguration and to the site of the aneurism. There may be radiopaquemarkers at a distal end of the stent graft delivery system or on thestent graft itself to allow the surgeon to guide the stent graft intothe proper position. Once in proper position, the stent graft can beexpanded from the radially-compressed configuration to theradially-expanded configuration. This can be done, for example, bypulling back a stent-graft cover, allowing the stent graft to expand dueto its fabric being biased outwards. Once deployed into theradially-expanded configuration, the stent graft can be held in placewith metallic hooks or stents. The catheter can then be removed, whilethe stent graft remains.

FIG. 1 shows an example of a stent graft 10 in its installed,radially-expanded configuration within a blood vessel 12, in this case apatient's aorta, more particularly the abdominal aorta. Once affixedwithin the blood vessel 12, the stent graft 10 provides a tube or pipefor blood flow, guiding the blood flow through the stent graft 10. Ifthe stent graft 10 is located within an aneurysm 11 of the blood vessel12, the blood flow through the stent graft 10 may reduce the pressurewithin the aneurysm and allow it to reduce in size (regress) or remainstable. In one embodiment, graft material of the stent graft 10 isnon-permeable, e.g., is polyester terephthalate (PET), expandedpolyester terephthalate (ePET), polytetrafluoroethylene (PTFE), or othernon-permeable graft material. As graft material is non-permeable, bloodor other fluid is prevented from passing through graft material.

As shown in FIG. 1, the stent graft 10 may include main body 14, a firstleg 16 extending from the main body 14, and a second leg 18 extendingfrom the main body 14. The first leg 16 may be ipsilateral to where theinitial guidewire was installed, and the second leg 18 that may becontralateral to the first leg 16, and may be shorter than the first leg16. The first leg 16 may extend into or toward a first iliac artery 20,while the second leg 18 may extend into or toward a second iliac artery22. The first and second legs 16, 18 may also guide blood flowtherethrough, allowing those portions of the iliac arteries to heal, andremoving stress from those regions of the arteries.

The first and second legs 16, 18 may be shorter than shown in FIG. 1,and may each provide a point of attachment for an additional stent graftthat extends into the iliac arteries. Secondary stent grafts maysubsequently be inserted within and attached to either or both of thefirst and second legs 16, 18 to elongate the overall profile of thestent graft. For example, once the initial stent graft 10 is deployedwith the first leg 16 and second leg 18 extending toward theirrespective iliac arteries, a surgical physician may then attachsecondary stent grafts to each respective leg 16, 18. Additional stentgrafts may also be attached to these secondary stent grafts within theiliac arteries. To do so, the surgical physician may run a guidewire upthe secondary stent graft attached to the first leg 16, through thefirst leg 16, into the main body 14 of the stent graft, and then downinto the second leg 18, and through the secondary leg attached to thesecond leg 18.

FIG. 2 illustrates one embodiment of a stent graft delivery system 30.The stent graft delivery system 30 can be used to delivery and deploy astent graft, such as the stent graft 10 of FIG. 1. In general, the stentgraft delivery system 30 may include an endovascular catheter and extendbetween a proximal end 32 and a distal end 34. A threaded screw gear 36extends along an axis between the proximal end 32 and the distal end 34.The threaded screw gear may be a multi-part shell configured to connecttogether to make a tubular screw gear. In one embodiment, the screw gear36 is two half-shells configured to connect (e.g., snap or assemble)together. A handle assembly 38 is provided for grip by the clinician.The handle assembly 38 may include two separable portions, namely afront grip 40 and an external slider 42. The front grip 40 may be fixedrelative to the screw gear 36, and the external slider 42 may rotateabout a threaded outer surface of the screw gear 36 to move linearlyalong the screw gear 36. For example, during deployment of a stentgraft, the external slider 42 is rotated to move toward the proximal end32. Since the external slider 42 is operatively coupled to a stent graftcover 44 surrounding the stent graft (e.g., stent graft 10), the stentgraft cover 44 is retracted with the linear movement of the externalslider 42. Meanwhile, a tip 46 at the distal end 34 of the deliverysystem 30, which has openings to track over the guidewires, can remainsteady within the vessel as the stent graft cover 44 is retracted awayfrom the tip 46. Retraction of the stent graft cover 44 allows the stentgraft to expand within the patient's vessel. Once the stent graft isdeployed, the entire stent graft delivery system 30 may be retractedfrom the patent's vessel.

The stent grafts described herein can be self-expanding, in that itincludes structures that are shaped or formed from a material that canbe provided with a mechanical memory to return the structure from acompressed or constricted delivery configuration to an expanded deployedconfiguration. Each stent grafts can include two main components: atubular graft, and one or more stents for supporting and expanding thegraft. The graft may be formed from any suitable graft material, forexample and not limited to, a low-porosity woven or knit polyester,DACRON material, expanded polytetrafluoroethylene, polyurethane,silicone, or other suitable materials. In another embodiment, the graftmaterial can also be a natural material such as pericardium or anothermembranous tissue such as intestinal submucosa. The stent isradially-compressible and expandable, is coupled to the graft materialfor supporting the graft material, and is operable to self-expand intoapposition with the interior wall of a body vessel (e.g., vessel 12) oranother stent graft. Each stent can be constructed from a self-expandingor spring material, such as but not limited to Nitinol, stainless steel,a pseudo-elastic metal such as a nickel titanium alloy or nitinol,various polymers, or a so-called super alloy, which may have a basemetal of nickel, cobalt, chromium, or other metal, or other suitablematerial. This allows the stent graft to expand when the stent graftcover 44 is retracted therefrom. The stent may be a sinusoidal patternedring including a plurality of crowns or bends and a plurality of strutsor straight segments with each crown being formed between a pair ofopposing struts.

The stent graft delivery system 30 may also include an access port 48.The access port 48 provides an opening for insertion of a secondaryguidewire lumen, or branching lumen, for surrounding a secondaryguidewire. Once the secondary guidewire lumen is inserted, the deliverysystem 30 can track along both the main guidewire and the secondaryguidewire during delivery of the stent graft. The access port 48 isoptional; other stent graft delivery systems that are configured fordelivering a non-branching stent graft may not include such an accessport, and the delivery system may track along a single guidewire.

For complex aortic disease that encroaches vessels such as the iliac, amajor barrier may be reducing procedural complexity while optimizingsurgical implant performance. However, the procedure explained above canbe complex at times. For example, the surgical physician may encountervarious obstacles (e.g., blockages in the artery causing a contortedprofile of the vessel) while attempting to feed the guidewire up one leg(e.g., leg 16), into the and into the other leg (e.g., leg 18) of thestent graft.

Therefore, according to various embodiments described herein, a numberof legs or stent grafts are provided with sacrificial entry/exit ports.The sacrificial ports may be on the first and and/or second legs, or onsecondary stent grafts attached to each leg. The sacrificial ports mayface one another, allowing the physician to add additional stent graftsto the stent-graft assembly without having to run a guidewire all theway up one leg, into the main body and then back down the other leg.Instead, the guidewire may be directed to exit one of the sacrificialports of one leg, and enter one of the sacrificial ports of the otherleg. This bypasses the main body of the stent graft, and provides ashorter distance of travel for the guidewire to reduce the complexity ofgoing up and over the bifurcated stent graft to gain access to thedesired vessel (e.g., the contralateral iliac artery).

FIG. 3 illustrates an example of a stent graft assembly 100 in aninstalled, radially-expanded configuration within a blood vessel 12,e.g., a proximal portion of an abdominal aorta. The stent graft assembly100 includes the branched stent graft 10 explained above. Alternatively,the stent graft assembly 100 can be provided with various other types orconfigurations of stent grafts. FIG. 3 once again shows an embodiment inwhich the stent graft 10 has a first leg 16 extending toward a firstiliac artery 20, and a second leg 18 extending toward a second iliacartery 22.

The stent graft assembly 100 also includes a first branch stent graft102 assembled to and extending from a distal end of the first leg 16,and a second branch stent graft 104 assembled to and extending from adistal end of the second leg 18. Each of the first branch stent graft102 and the second branch stent graft 104 can have similar material andstructural makeup as the stent graft 10 explained above. In oneembodiment, a proximal end of the first branch stent graft 102 isdelivered within the first leg 16 and expanded to couple (e.g., fasten,hook, latch, etc.) to a distal end of an inner wall of the first leg 16.The same process can be done for the second branch stent graft 104within the second leg 18. In an alternative embodiment, the first branchstent graft 102 is continuous and part of the first leg 16 and deliveredtherewith, and/or the second branch stent graft 104 is continuous andpart of the second leg 18 and delivered therewith.

Upon deployment, the first branch stent graft 102 may extend into thefirst iliac artery, and the second branch stent graft 104 may extendinto the second iliac artery 22. Each branch stent graft 102, 104 mayalso have legs or portions that extend into tributary vessels of thepatient's vasculature. For example, in the embodiment shown in FIG. 3,the second branch stent graft 104 includes a portion or leg 106 thatextends further into the second iliac artery 22 or a tributary vessel108. The second branch stent graft 104 may also include a portion or leg110 that extends toward, but not into, another tributary vessel 112(e.g., internal iliac artery). The portion or leg 110 may provide anaccess port for access and delivery of additional stent grafts into thattributary vessel 112. Likewise, the portion or leg 106 may provide anaccess port and attachment point for access and delivery of additionalstent grafts into that tributary vessel 108.

One or both of the branch stent grafts 102, 104 may include sacrificialentry/exit ports. For example, the first branch stent graft 102 mayinclude a first sacrificial entry/exit port 120, and the second branchstent graft 104 may include a second sacrificial entry/exit port 122.These sacrificial ports are sized and configured to receive a guidewiretherethrough for tracking and delivery of a surgical device of anotherdelivery system.

FIG. 4A illustrates the use of the sacrificial ports 120, 122 fordelivering a guidewire 124 from the first stent graft 102 to the secondbranch stent graft 104. This configuration allows the guidewire 124 toreach a destination (e.g., second iliac artery 22) without having totravel up and into the stent graft 10, or at least the main body 14thereof. In this embodiment, the first sacrificial port 120 is an exitport as the guidewire 124 exits the first branch stent graft 102therethrough, and the second sacrificial port 122 is an entry port asthe guidewire 124 enters the second branch stent graft 104 therethrough.

As shown in FIG. 4A, the first branch stent graft 102 and second branchstent graft 104 may be positioned such that the respective sacrificialports 120, 122 face one another. For example, both ports may facemedially or towards the sagittal plane. In one embodiment, the exit portmay be configured to be above (e.g., superior or cranial) the entryport. These relative positions may facilitate the exit of the guidewire124 through the first sacrificial port 120 at a location that isadjacent to the second sacrificial port 122 to minimize a length oftravel of the guidewire 124.

As also shown in FIGS. 4A-4B, the opening of each port 120, 122 may facegenerally proximally (i.e., upstream toward the heart) so that theguidewire 124 can exit the first sacrificial port in a direction that isgenerally aligned with the direction that the guidewire 124 is fed intothe patient. Once the guidewire 124 is fed beyond the first sacrificialport 120, the guidewire 124 can then be bent to change direction to befed the distal direction (e.g., downstream away from the heart)whereupon it enters the proximally-facing second sacrificial port 122.However, in other embodiments, the ports may face in differentproximal/distal directions. For example, the exit port may facegenerally distally while the entry port faces generally proximally. Thisconfiguration may allow the guidewire to be aligned or generally alignedwith the entry port as it exits the exit port, which may facilitateeasier cannulation of the entry port. In this configuration, the exitport may be configured to be above (e.g., superior or cranial) the entryport.

Each sacrificial port 120, 122 may include extensions of material (e.g.,graft material) of the respective branch stent grafts, and may besupported by reinforcement structures such as stent structures. Thegraft material of the sacrificial ports 120, 122 may extend fromfenestrations or openings in the branch stent grafts to define a lumentherethrough. The graft material of the ports may be formed integrallyor seamlessly with the branch stent graft (e.g., during the materialweaving process) or the components maybe formed separately and securedtogether (e.g., with sutures). In certain embodiments, each sacrificialport 120, 122 has a self-expanding reinforcing ring at its internaland/or external end to maintain the port in an open configuration. Otherembodiments of opening and closing the sacrificial ports 120, 122 aredescribed below. External ends of each sacrificial port 120, 122 may beprovided with a radiopaque marker to facilitate the exit and entrance ofthe guidewire therethrough.

Once the guidewire 124 has passed through the sacrificial ports 120,122, a delivery system (not shown) may be tracked along the guidewire124 and into the desired location, e.g., into the second iliac artery22. Once there, this delivery system may deploy another stent graft, orother surgical tool. The delivery system and guidewire 124 can then beretracted.

After the sacrificial ports 120, 122 have been used for this delivery ofthe guidewire 124 and tracking procedure/deployment, it may be desirableto close the sacrificial ports 120, 122. Closing these ports 120, 122assures blood is directed through the stent graft assembly 100, and doesnot travel into the regions between the stent graft assembly 100 and thevessel 12 itself. This allows the stent graft assembly 100 to properlycontain the flow of blood therein, allowing the aneurism to heal.

FIG. 4B shows the sacrificial ports 120, 122 closed, as represented byrespective general closures 130, 132. The closures 130, 132 can includeone or more of many potential mechanics for closing the ports 120, 122.In one embodiment, at least one of the closures 130, 132 includes a pullwire that, when pulled by the guidewire or other surgical instrument,cinches the external end of the port closed. In yet another embodiment,at least one of the closures 130, 132 includes an inwardly-biased ringthat, when broken or otherwise activated by the guidewire or othersurgical instrument, contracts and closes. At least one of the closures130, 132 may be biased open, whereupon a force can be applied to theclosure to occlude the respective port 120, 122 after use of the ports120, 122. In addition, or alternatively, at least one of the closures130, 132 may be biased closed, whereupon a force can be applied (e.g.,inserting a delivery system) to open the closure for use of the ports120, 122 and removal of the force (e.g., withdrawing a delivery system)causes the closures to return to a closed state.

FIGS. 4C-4K illustrate various embodiments of the closure 130 of thesacrificial port 120, with various mechanisms for closing the port 120.In each of these Figures, there is an “open” view in which thesacrificial port 120 is open (e.g., for passing a guidewire 124 ordelivery system therethrough as explained above), and a “closed” view inwhich the sacrificial port 120 has been subsequently closed to inhibitblood flow therethrough. While sacrificial port 120 is shown in each ofthese Figures, it should be understood that identical or similarstructure can be provided in the other sacrificial port 122 with itsrespective closure 132. Alternatively, ports 120 and 122 may usedifferent closure mechanisms, which may be mixed and matched from thosedisclosed herein.

In an embodiment illustrated in FIG. 4C, an internal sack or ring 140can be coupled to an internal wall 142 of the port 120. The ring 140 canbe inflated (e.g., with saline) to expand inwardly to close off the port120. The inflatable ring can be elastic. Excessive inflatable materialcan be provided initially in the ring that accommodates and facilitatesthe entry/exit of the guidewire 124 and associated delivery system dueto a vacuum or absence of fluid in the ring prior to closure of the port120.

In an embodiment illustrated in FIG. 4D, an external ring 144 can beprovided about an external surface 146 of the port 120. Similar to theembodiment of FIG. 4C, the external ring 144 can be inflated (e.g., withsaline). This compresses the port 120 inwardly to close the port 120.The embodiments shown in FIGS. 4C and 4D may include an inflation lumenthat is connected to a source of fluid (e.g., saline) in order toinflate the ring. The inflation lumen may be similar to those used ininflatable medical balloons (e.g., for angioplasty).

In an embodiment illustrated in FIG. 4E, a pull wire or string 150 wrapsaround the port 120 and extends outwardly therefrom. The pull wire orstring can extend out of the patient's body, or at least to anadditional tool within the patient's body. The surgical technician ortool can apply tension to the pull wire or string, collapsing the port120. The port 120 can either be biased open or biased closed, and a pullwire or string can be used to either close the biased-open port or openthe biased-closed port. In one embodiment, a knot (e.g., slip knot,hitch knot, etc.) can be used to secure the pull wire or string aboutthe port 120, and pulling of the wire or string can untie or release theknot, allowing the port 120 to open via the stent at the port 120 thatis biased to close. In another embodiment, other closures besides knotscan be employed. For example, a staple- or plug-based closure can securethe suture in the closed configuration.

In an embodiment illustrated in FIG. 4F, the end of the port 120 may beprovided with a stent 152. The stent may have alternating peaks. Thestent may be oversized compared to its respective port 120. Alternatingstent peaks can be attached to the port and another ring 154 of materialcan be attached to the stent peaks that expands outwardly. The additionof the ring 154 of material can be a continuation of the fabric of thegraft material of the port 120, folded back over the exterior of theport 120 at a larger diameter than the opening of the port. A wire 156or string can run along the interior surface of the port 120 to thesurgical technician, whereupon the technician can pull tension on thewire 156 or string to cause the stent end of the port to invert. Thisresults in the stent peaks of the ring 154 to close off the port 120.

In an embodiment illustrated in FIG. 4G, two wires 160, 162 or stringscan be attached to opposing sides of the opening of the port 120, andrun back to the surgical technician. The technician can twist the wiresor strings to correspondingly twist the port 120, causing it tocollapse. The two wires 160, 162 or strings at the port 120 can then betied in a knot to secure the closure of the port 120.

In an embodiment illustrated in FIG. 4H, a piece of elastic material 164(e.g., ring, string, strip, etc.) may wrap about the port 120. Theelastic material 164 may be biased in its closed position to close theport, but expands when a delivery system or accessory is placed throughit. When the delivery system or accessory is removed, the elasticmaterial 164 returns to its natural shape to close the port. While onlyone piece of elastic material 164 is shown, in other embodiments therecould be several pieces of elastic material at spaced-apart locationsalong the port 120.

In an embodiment illustrated in FIG. 41, an elastic ring 166 is providedabout the port 120 at an end thereof. The ring 166 may be inflatablewith fluid (e.g., saline). In its normal configuration without beinginflated, the ring 166 may be closed, and providing fluid to the ring166 may expand the ring 166 and the attached port 120 to the openconfiguration. An inflation lumen and source may be provided, asdescribed above.

In an embodiment illustrated in FIG. 4J, a spiral wire 168 extends aboutthe exterior of the port 120 and has a loop 170 at either end. Thespiral wire 168 in its natural state collapses the port 120, but whenthe spiral wire 168 is rotated against its spiral direction, the port120 is expanded to open. The spiral wire 168 can be rotated to open theport 120, and a stiff wire (not shown) can be placed through the twoloops 170 of the spiral wire 168 to prevent the spiral wire fromrotating back and closing the port 120. Once the stiff wire is removed,the spiral wire 168 is biased to rotate back to its natural state tocollapse the port 120.

In an embodiment illustrated in FIG. 4K, the port 120 is provided withan internal stent 172 having alternating stent peaks. The internal stent172 is attached to an external graft material 174 and an internal graftmaterial 176. The internal graft material 176 can be a separate piece ora continuation of the external graft material 174. At least one of theproximal peaks of the internal stent 172 is biased to collapse in, andcan be held open by suturing or tying it via suture 178 to the externalgraft material. The suture 178 can be pulled to remove from the port120, resulting in the internal graft material 176 and peaks of theinternal stent 172 collapsing inward.

In another embodiment, the port 120 may be provided with an envelope ofmaterial containing a hydroscopic material (e.g., hydrogel) that absorbsliquid from blood and swells within the envelope. Therefore, the ports120, 122 may be initially inserted into the patient in a contractedposition, and absorption of blood within the envelopes over timegradually closes the ports 120, 122. Generation of hydrostatic pressurewithin the envelope closes off the opening at a predictable and tunablerate.

In another embodiment, the ports 120, 122 may be closed via a deliveryof a secondary occlusion device over the guidewire after manipulationthrough the ports 120, 122 is complete. The secondary occlusion devicemay be used to selectively occlude the respective port 120, 122 itself.The secondary occlusion device may be a covered stent-based or coil/Nitinol mesh-based occlusion system. The secondary occlusion device maybe deployed into the corresponding port 120, 122, or if the port 120,122 is a simple fenestration, the secondary occlusion device can be arivet structure.

In another embodiment, the closure of the ports 120, 122 can beperformed via delivery of a secondary stent graft cuff that walls offthe port from the luminal (e.g., interior) side of the graft aftermanipulation through the port 120, 122 is complete.

At least one of the closures 130, 132 may be biased closed, whereupon aforce can be applied to open the closures temporarily for the deliveryof the guidewire 124 and associated delivery system. In one embodiment,a piece of elastic material (e.g., a string or stent around the end ofeach port 120, 122) can be biased in a collapsed configuration tomaintain the closures 130, 132 closed. These pieces of material can beforced to expand when a guidewire or delivery system is placedtherethrough.

In another embodiment, a spiral wire extends about the exterior of eachport 120, 122, and each spiral wire has a loop at either end. Eachspiral wire in its natural state collapses the ports 120, 122, but whenthe spiral is rotated against its spiral direction, the ports 120, 122are expanded to open. The spiral wire can be rotated to open the ports120, 122, and a stiff wire can be placed through the two loops of eachspiral wire to prevent the spiral wire from rotating back and closingthe respective port 120, 122. Once the stiff wire is removed, the spiralwire is biased to rotate back to its natural state to collapse theassociated port.

FIGS. 5A-5B show another embodiment of a stent graft assembly, in whicha staged deployment is utilized to block off a sacrificial port once theport has served its purpose. In this embodiment, an internal cuff withinthe stent graft can be released as part of a staged deployment thatwalls off the sacrificial port of the stent graft from the luminal sideonce the sacrificial port has served its purpose of allowing accessthrough the stent graft.

Referring to FIG. 5A, a stent graft assembly 200 is shown within a bloodvessel 12, e.g., a proximal portion of an abdominal aorta. The stentgraft assembly 200 includes a first stent graft or main stent graft 202.The main stent graft 202 is shown to be partially deployed within theabdominal aorta, specifically within the second (e.g., left) iliacartery 22. The main stent graft 202 may be a branched stent graft, suchas those described above, with a first leg or main leg 204 extendingfurther into a main portion 108 of the iliac artery 22, and a second leg206 extending in a direction toward a tributary vessel 112 (e.g.,internal iliac artery). It should be understood that the vessels shownin FIGS. 5A-5B are merely exemplary, and the teachings of the stentgraft assembly 200 described herein can be applied to other vesselsthroughout the body. As shown in FIGS. 5A and 5B, a stent graft cover208 covers a portion of the main leg 204 to not allow the main leg 204to fully deploy. In other embodiments, the stent graft cover 208 isremoved so that the main leg 204 is in its fully-deployed configurationwithin the iliac artery 22.

Referring to FIG. 5A, a guidewire 210 extends through the main stentgraft 202 for delivery thereof. The stent graft cover 208 and associateddelivery system tracks along this guidewire 210. The main stent graft202 also has a sacrificial entry/exit port 212. This port 212 can beformed of the structure described in embodiments above. For example, thesacrificial port 212 can be an extension of graft material of the stentgraft 202, can have its own stents or elastic members, can have acollapsible ring on its outer edge, or other embodiments describedabove. In short, the sacrificial port 212 can be similar to thesacrificial ports 120, 122 described above. The sacrificial port 212 canalso have its own closure that operates similar to the closures 130, 132described in the various embodiments above. Additional disclosure ofclosing the sacrificial port 212 is provided below.

The sacrificial port 212 provides access to a secondary stent graftdelivery system 220. The secondary stent graft delivery system 220 canextend along its own dedicated guidewire 222. During operation, theguidewire 222 can be fed from the first iliac artery 20, into thesacrificial port 212, and down into the second leg 206. The secondarystent graft delivery system 220 can then track along this guidewire 222to a desired deployment location within the vessel 112 (e.g., internaliliac artery).

The sacrificial port 212 reduces the required length of travel of theguidewire 222 and secondary stent graft delivery system 220. Instead oftraveling all the way up to the proximal opening of the stent graft 202,entrance into the stent graft 202 can be made through the sacrificialport 212 which can be located adjacent the second leg 206, or closer tothe second leg 206 than the proximal opening of the stent graft 202.Said another way, the sacrificial port 212 allows the secondary stentgraft delivery system to enter the main body of the stent graft 202while bypassing the length of the main body of the stent graft locatedmore proximal (e.g., up, in the orientation of FIG. 5A) of thesacrificial port 212

As mentioned above, the sacrificial port 212 can be closed similar tothe methods described above with reference to closures 130, 132.However, FIGS. 5A-5B illustrate an additional method of closing thesacrificial port 212. This embodiment can likewise be applied to thestent graft assemblies of previous embodiments.

In this embodiment, the stent graft assembly 200 is provided with aninternal cuff 230. The internal cuff 230 may be a stent graft, having agraft material as a main body and one or more stents extending about thegraft material for self-expanding, similar to other stent graftsexplained herein. The internal cuff 230 can remain in a constricted,undeployed, or semi-deployed configuration as shown in FIG. 5A while thesecondary stent graft delivery system 220 is passed through the stentgraft 202 and into the vessel 112. This provides clearance within thestent graft 202 so that the internal cuff 230 does not interfere withthe delivery of the secondary stent graft delivery system 220 throughthe stent graft 202.

After the secondary stent graft delivery system 220 has properlydelivered a stent graft or performed other necessary functions, thedelivery system 220 can be removed through the sacrificial port 212.Subsequently, the sacrificial port 212 can be closed. One embodiment ofclosing the sacrificial port 212 is shown in FIG. 5B. In thisembodiment, the internal cuff 230 is expanded outwardly to an expandedconfiguration within the stent graft 202 such that the internal cuff 230covers the sacrificial port 212. This inhibits blood in the vessel 12from entering or exiting the stent graft 202 through the sacrificialport 212. This also provides additional structural support to the stentgraft 202 from within. In one embodiment, the cuff 230 is a stent graftthat is biased to expand to a size radially equal to or greater than themain stent graft 202, thus providing a force against the interiorsurface of the stent graft 202 to properly close and seal thesacrificial port 212. Another way to expand the internal cuff 230outwardly is to perform a staged deployment procedurally. Rather thanbuilding in a second unified stent that is released as part of thedeployment, the sacrificial port can be closed with a bridging stentthat connects the stent graft 202 to a bifurcated stent graft (notshown). In that embodiment, the bridging stent can dock into thebifurcated stent graft and extend to a location just distal to thesacrificial port 212, closing it off from circulation. The distal end ofthe bridging stent can end just prior to the proximal portion of thesacrificial port 206, thus maintaining the patency of the branch.

As shown and explained with reference to FIGS. 5A-5B, the internal cuff230 can be deployed in stages. For example, in FIG. 5A, the internalcuff 230 may be only partially deployed, and in FIG. 5B, the internalcuff 230 may be fully deployed. Such a staged deployment can beperformed in a plurality of embodiments, two of which are shown in FIGS.6A-6B and 7A-7B.

FIGS. 6A-6B illustrate one embodiment of a staged-deployment system 300for closing a sacrificial port of a stent graft. The system includes ageneral stent graft 302 with a sacrificial port 304, which can besimilar to embodiments explained above such as stent graft 202 andsacrificial port 212. In other words, the teachings of thestaged-deployment system 300 can be implemented into various embodimentsabove, such as those described with reference to FIGS. 5A-5B.

The staged-deployment system 300 includes an internal cuff 306, whichmay be an expandable stent graft made of a graft material and having aplurality of stents 308 biased to expand the stent graft radiallyoutwardly. One or more suture loops 310 may be attached to the graftmaterial of the internal cuff 306. The suture loops 310 are configuredto constrain the stents 308 such that the internal cuff 306 ismaintained in a constricted configuration. The suture loops 310 may eachbe looped about itself, such that two looped ends are attached with eachlooped end extending through the other looped end (e.g., like a chain).A trigger wire or release wire 312 extends through looped ends of thesuture loops 310, keeping the suture loops 310 closed and preventing theexpansion of the stents 308.

As the release wire 312 is pulled out of the internal cuff 306, thelooped ends of the suture loops 310 are free to separate, thus allowingthe stents 308 to expand. This is shown in FIG. 6B. As the internal cuff306 is allowed to expand, it covers the sacrificial port 304 to blockblood flow therethrough. As used herein, the term suture loops may referto surgical sutures, but also may include any wire, thread, or filamenttype structure (e.g., not limited only to surgical sutures).

FIGS. 7A-7B illustrate another embodiment of a staged-deployment system400 for closing a sacrificial port of a stent graft. Once again, thesystem includes a general stent graft 402 with a sacrificial port 404,which can be similar to embodiments explained above such as stent graft202 and sacrificial port 212. In other words, the teachings of thestaged-deployment system 400 can be implemented into various embodimentsabove, such as those described with reference to FIGS. 5A-5B.

The staged-deployment system 400 includes an internal cuff 406 which,once again, can be an internal stent graft located within the main stentgraft 402. A sheath or cover 408 may be provided about the internal cuff406 to keep the cuff 406 in a constricted configuration. The cover 408may be made of a pliable material such as, for example, the samematerial as the graft material of the stent grafts described herein. Thecover 408 may be discontinuous, in that it is not a single,uninterrupted piece of material that surrounds the internal cuff 406.Instead, the cover 408 may have a gap 410 between two ends thereof.

A removeable suture 412 (e.g., wire, thread, or filament type structure)may be used to tie the two ends of the cover 408 together, thusconstraining the internal cuff 406 therein. The suture 412 may bethreaded through the gap 410 of the cover 408. Removal of the sutureallows the ends of the cover 408 to separate, thus allowing the internalcuff 406 to expand to an expanded configuration and close off thesacrificial port 404. The internal cuff 406 may be removed with theremoveable suture or by a separate mechanism (e.g., a dedicated tether).Alternatively, the cuff may be pinned to the main graft wall by the cuffduring its expansion.

While exemplary embodiments are described above, it is not intended thatthese embodiments describe all possible forms encompassed by the claims.The words used in the specification are words of description rather thanlimitation, and it is understood that various changes can be madewithout departing from the spirit and scope of the disclosure. Aspreviously described, the features of various embodiments can becombined to form further embodiments of the invention that may not beexplicitly described or illustrated. While various embodiments couldhave been described as providing advantages or being preferred overother embodiments or prior art implementations with respect to one ormore desired characteristics, those of ordinary skill in the artrecognize that one or more features or characteristics can becompromised to achieve desired overall system attributes, which dependon the specific application and implementation. These attributes caninclude, but are not limited to cost, strength, durability, life cyclecost, marketability, appearance, packaging, size, serviceability,weight, manufacturability, ease of assembly, etc. As such, to the extentany embodiments are described as less desirable than other embodimentsor prior art implementations with respect to one or morecharacteristics, these embodiments are not outside the scope of thedisclosure and can be desirable for particular applications.

What is claimed is:
 1. A staged-deployment stent graft assemblycomprising: a main stent graft having a sacrificial port extendingtherefrom, the main stent graft having a compressed state and anexpanded state; and an internal stent cuff located within the stentgraft, the internal stent cuff having a constricted state and anon-constricted state, the internal stent cuff biased to expand from theconstricted state to the non-constricted state to close the sacrificialport when the main stent graft is in the expanded state.
 2. Thestaged-deployment stent graft assembly of claim 1, further comprising: afilament structure maintaining the internal stent cuff in theconstricted state; and a release configured to manipulate the filamentstructure to transition the internal stent cuff from the constrictedstate to the non-constricted state to close the sacrificial port whenthe main stent graft is in the expanded state.
 3. The staged-deploymentstent graft assembly of claim 2, wherein the filament structure isformed from wires or threads.
 4. The staged-deployment stent graftassembly of claim 2, wherein the release is a wire release.
 5. Thestaged-deployment stent graft assembly of claim 1, wherein the mainstent graft has a main body and first and second legs extending from themain body.
 6. A staged-deployment stent graft assembly comprising: amain stent graft having a sacrificial port extending therefrom, the mainstent graft having a compressed state and an expanded state; an internalstent cuff located within the stent graft, the internal stent cuffhaving a constricted state and a non-constricted state; filament loopsmaintaining the internal stent cuff in the constricted state; and arelease configured to manipulate the filament loops to transition theinternal stent cuff from the constricted state to the non-constrictedstate to close the sacrificial port when the main stent graft is in theexpanded state.
 7. The staged-deployment stent graft assembly of claim6, wherein the internal stent cuff includes a graft material and stents,and the filament loops are attached to the graft material to constrainthe stents to maintain the internal stent cuff in the constricted state.8. The staged-deployment stent graft assembly of claim 7, wherein thefilament loops are axially aligned with the stents of the internal stentcuff
 9. The staged-deployment stent graft assembly of claim 6, whereinthe filament loops are looped about themselves such that first andsecond looped ends of each filament loop extend through each other. 10.The staged-deployment stent graft assembly of claim 9, wherein therelease is a release wire extending through the first and second loopedends of each filament loop to maintain the filament loops in a closedposition.
 11. The staged-deployment stent graft assembly of claim 10,wherein the filament loops are configured to separate when the releasewire is released from the filament loops, thereby allowing the internalstent cuff to transition from the constricted state to thenon-constricted state.
 12. The staged-deployment stent graft assembly ofclaim 6, wherein the filament loops are formed from sutures.
 13. Thestaged-deployment stent graft assembly of claim 6, wherein the filamentloops are formed from wires or threads.
 14. A staged-deployment stentgraft assembly comprising: a main stent graft having a sacrificial portextending therefrom, the main stent graft having a compressed state andan expanded state; an internal stent cuff located within the stentgraft, the internal stent cuff having a constricted state and anon-constricted state; a sheath maintaining the internal stent cuff inthe constricted state and having first and second ends; and a removabletie configured to tie the first and second ends of the sheath, when theremovable tie is removed, the internal stent cuff transitions from theconstricted state to the non-constricted state to close the sacrificialport when the main stent graft is in the expanded state.
 15. Thestaged-deployment stent graft assembly of claim 14, wherein the firstand second ends form a gap therebetween.
 16. The staged-deployment stentgraft assembly of claim 14, wherein the removable tie is a removablesuture.
 17. The staged-deployment stent graft assembly of claim 16,wherein the removable suture alternates stitches between the first andsecond ends of the sheath.
 18. The staged-deployment stent graftassembly of claim 14, further comprising a tether configured to removethe sheath after the internal stent cuff transitions into thenon-constricted state.
 19. The staged-deployment stent graft assembly ofclaim 14, wherein the sheath is pinned to the main stent graft by theinternal stent cuff when the main stent graft is in the expanded stateand the internal stent cuff is in the non-constricted state.
 20. Thestaged-deployment stent graft assembly of claim 14, wherein theremovable tie is formed from wires or threads.